26887 Effect of ruxolitinib cream on sleep disturbance and sleep impairment: Pooled analysis from two randomized phase 3 studies

Abstract

Atopic dermatitis (AD) is a chronic, inflammatory skin disease. Patients’ quality of life is significantly impacted by pruritus leading to sleep disturbances. Ruxolitinib is a Janus kinase (JAK) 1/JAK2 inhibitor, and a cream formulation of ruxolitinib has demonstrated potent anti-inflammatory and antipruritic effects in patients with AD. Two phase 3 randomized studies (TRuE-AD1 [NCT03745638]; TRuE-AD2 [NCT03745651]) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator’s Global Assessment score of 2 or 3, and 3%–20% affected body surface area. Patients (N = 1249 in both studies combined; median age, 32 years) were randomized (2:2:1) to 0.75% ruxolitinib, 1.5% ruxolitinib, or vehicle cream (all twice daily) for 8 weeks of double-blind treatment. Sleep quality was assessed using the previously validated Patient-Reported Outcome Measures Information System (PROMIS) Sleep-Related Impairment (SRI [8a]) and Sleep Disturbance (SD [8b]) Short Form questionnaires, which were modified to be completed daily with a 24-hour recall; patients with missing postbaseline values were imputed as nonresponders. At Week 2, more patients treated with ruxolitinib achieved ≥6-point improvement from baseline (clinically meaningful) vs vehicle for SRI (0.75% ruxolitinib, 13.6%; 1.5% ruxolitinib, 13.3%; vehicle, 8.0%) and SD (0.75% ruxolitinib, 14.1%; 1.5% ruxolitinib, 16.3%; vehicle, 7.5%). Responses increased over time, indicating progressive sleep improvement at Week 8 in SRI (0.75% ruxolitinib, 20.1%; 1.5% ruxolitinib, 22.3%; vehicle, 13.3%; both P ˂ .05) and SD (0.75% ruxolitinib, 20.9%; 1.5% ruxolitinib, 23.8%; vehicle, 14.2%; both P ˂ .05). In summary, ruxolitinib cream demonstrated early and progressive improvements in SRI and SD in patients with AD.